MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Device Problems Migration or Expulsion of Device (1395); Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Patient¿s date of birth and weight are unknown.Date of postoperative screw pulled out is unknown.510k: this report is for two (2) screws.From the following reported screws; it is unknown which two (2) screws pulled out postoperatively.Without the specific part and lot numbers, the udi number is not available.One (1) 4.5mm ti occipital screw 10mm (part # 04.601.110); one (1) 4.5mm ti occipital screw 8mm (part # 04.601.108); two (2) ti axon(tm) locking screw stardrive (part # 406.104).Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was 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.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that a patient underwent a revision of oc-c4 psf on (b)(6) 2018.Primary surgery was performed on (b)(6) 2018.On an unknown postoperative date, the two (2) screws pulled out of the patient¿s occiput and loosened the plate, which came away from the occiput.The surgeon felt that the position of the patient¿s head contributed to the loosening as he wasn't to look down more.The surgeon chose to implant only two (2) instead of three (3) screws into the medial plate during the primary procedure.Patient revised to a new plate with rescue screws, primary screws, new rods and axon set screws.There was no surgical delay reported.Patient¿s outcome reported as unknown.Concomitant devices reported: 4.5mm ti occipital screw 10mm (part # 04.601.110, lot # unknown, quantity 1), 3.5mm ti pre-bent rod 240mm 110deg (part # 04.161.032, lot # unknown, quantity 2); ti axon(tm) locking screw stardrive (part # 406.104, lot # unknown, quantity 2), ti occipital plate-medial 50mm width (part # 04.161.001, lot # unknown, quantity 1); 4.5mm ti occipital screw 8mm (part # 04.601.108, lot # unknown, quantity 1).This report is for two (2) unknown screws.This is report 1 of 1 for complaint (b)(4).

• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7365944
• MDR Text Key: 103321794
• Report Number: 8030965-2018-52351
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2018
• Initial Date FDA Received: 03/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention