MAUDE Adverse Event Report: SYNTHES BRANDYWINE PRODISC-C IMPLANT LARGE 5MM-STERILE; PROSTHESIS INTERVERTEBRAL DISC

Catalog Number 09.820.045S

Device Problems Break (1069); Fitting Problem (2183)

Patient Problem No Code Available (3191)

Event Date 08/22/2016

Event Type  Injury  

Manufacturer Narrative

This device was used for treatment, not diagnosis.(b)(4).Device has been lost in transit.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.The review of dhr for part# 09.820.045.1 lot# 7921113 found one incoming defect report (idr), initiated by supplier (b)(4) for a visual nonconformity on (b)(4) parts.The parts were processed normally and evaluated at incoming inspection.Inspection sheet showed all parts passed inspection requirements.The visual non-conformances identified prior to the coating process are not related to the complaint condition.The review of dhr for part# 09.820.045.2 lot# 7919245 found one incoming defect report (idr), initiated by supplier (b)(4) for (b)(4) parts containing scratches and (b)(4) parts with a scuff on zone d.The parts were processed normally and evaluated at incoming inspection.Inspection sheet showed all parts passed inspection requirements.The visual non-conformances identified prior to the coating process are not related to the complaint condition.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that during a surgery for a prodisc-c disc (pdc) replacement on (b)(6) 2016; while the surgeon was implanting the pdc implant at disc level c5-c6 the instruments that hold the spacer broke.Under fluoroscopy, while using the mallet with the inserter tip on the implant holder and the pdc implant, the surgeon noted that upon implanting the spacer, it went past the vertebral wall.The surgeon stated that the implant was encroaching on the spinal canal and the surgeon attempted to pull back on the inserter tip, but the holder implant device would not move.The surgeon manipulated the inserter instruments by moving the spacer up and down and side to side.The inserter tip would not release from the pdc implant and the tip portion of the inserter instrument broke off.Under fluoroscopy, all fragments were retrieved and the pdc implant was successfully removed.Due to this event an additional twenty (20) minutes was added to operating room time.The surgeon was also concerned that the keel channel groves that were previously introduced during preparation of the disc spacer would comprise the placement of another pdc implant.His concern was that the canals would cause a larger chance for migration of the implant but the patient was revised to the anterior cervical discectomy fusion (acdf).It was reported that the surgery was completed successful and the patient is in stable condition.This report is 1 of 3 for (b)(4).

Manufacturer Narrative

Expiration date.(other): udi # (b)(4).Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.The following devices were returned: part# 03.820.129, lot# t925467; part# 09.820.045s, lot# h051160; part# 03.820.133s, lot# h089808.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended.Part# 03.820.129, lot# t925467.A visual inspection and drawing review were performed as part of this investigation.The prodisc-c implant inserter (03.820.129 lot t925467) is a component of the prodisc-c instrument and implant set (01.820.003) which is intended to be used in conjunction with the prodisc-c system.The prodisc-c system is used to ¿replace a diseased and/or degenerated intervertebral disc of the cervical spine¿.The implant inserter is specifically utilized to insert prodisc-c implants after keel preparation.An appropriate inserter tip is attached to the inserter and the implant is engaged onto the implant.With the implant loaded, the inserters locking nut is tightened to firmly lock the implant into position.The implant can then be inserted into the opening under fluoroscopic control (per prodisc-c technique guide).The returned instrument was evaluated and the complaint condition of broken tip was able to be confirmed.The part was received with the distal tip of the up handle broken off.The fragment was returned and it measured 4.62mm in length.The balance of the device is in fair condition with signs of wear and tear.Relevant drawings were reviewed.The design history was found to not impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.No definitive root cause can be determined however the failure mode maybe due to the method to which the surgeon was using to remove the instrument during the procedure.Part# 09.820.045s, lot# h051160, part# 03.820.133s, lot# h089808.These devices were determined to be concomitant devices as no complaint allegations were made against them, only that surgeon pushed the spacer past the vertebral wall and no issues were noted on either device.Therefore no further investigation is required at this time.The device was initially reported as lost in transit.The device was located on aug 26, 2016.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.A manufacturing investigation was performed for part# 09.820.045s, lot# h051160.The assembly was separated into two pieces.One piece contained assembled part# 09.820.045.2 (superior plate) while the other piece was assembled in two pieces, component part#s 09.820.045.1 (inferior plate) and 09.820.045.3 (inlay).Assembly was separated into two pieces.All two pieces received, had scratches, blemishes, and surface defects.Part# 09.820.045.2 (superior plate) slot end shows spread.Slot on superior plate where it spreads has nicks, dents, and spread out than normal.Zrinski medical industrial manufactured the part # 09.820.045.1 inferior plate, lot number 7921113, part # 09.820.045.2 superior plate, lot # 7919245 & part # 09.820.045.3 inlay large 5mm lot # 9861523.Final assembly part # 09.820.045s was done at (b)(4) plant & sterilized at supplier.At the time of original manufacturing, the parts conformed to inspection requirements.The product material was confirmed to be correct and the undamaged dimensions were verified to be within tolerance.Part# 09.820.045.1 and 09.820.045.3 are not able to separate for measurement since returned part is still assembled.Based on the unknown root cause and the evaluation performed, the complaint condition is confirmed but not related to a manufacturing cause.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PRODISC-C IMPLANT LARGE 5MM-STERILE
• Type of Device: PROSTHESIS INTERVERTEBRAL DISC
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5935037
• MDR Text Key: 54139221
• Report Number: 2530088-2016-10238
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Catalogue Number: 09.820.045S
• Device Lot Number: H051160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR