MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: 4.5 MM NARROW LIMITED CONTACT LOCKING COMPRESSION PLATES (LC-LCP); PLATE, FIXATION, BONE

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report is for an unk - screws: spine/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: reporter is a j&j representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the surgeon set the plate for the guiding block at the demonstration.After the demonstration, by using the drill sleeve to remove the plate from the guiding block, but the plate couldn't be removed from the guiding block.Finally, remove the guiding block about 30 minutes.No further information is available.This complaint involves three(3) devices.This report is for (1) unk - plates: 4.5 mm narrow limited contact locking compression plates (lc-lcp) this report is 3 of 3 for (b)(4).

• Brand Name: UNK - PLATES: 4.5 MM NARROW LIMITED CONTACT LOCKING COMPRESSION PLATES (LC-LCP)
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12367172
• MDR Text Key: 268130367
• Report Number: 8030965-2021-07200
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 07/28/2021
• Initial Date FDA Received: 08/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: GUIDINGBLOCK F/LOCKING ATTACHMENT PLATE.; LCP DRILL SLEEVE 3.5 F/DRILL BIT Ø2.8 03.