MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SINGLE-INNER SETSCREW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 179702000

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint: (b)(4).Surgical intervention in the form of revision surgery.(b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.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 the patient operated with expedium 5.5 ca 1 year ago.The rod had slipped out of the patient, leaving the construction not satisfying.Patient was fine for the first months after first surgery.Then after a while he got more back problem again.Reoperation shows that some of the sets screw on the distal part of the construction was not that hard to open (seemed like they were not as tight as they should be, final tightening was done by doctors during surgery first time).On the right side the rod was just inside the distal screw, almost on it-s way out as well.Construction was from l2 to s1 with ilium screws bilat.The one ilium screw the whole tulip just had loosen from it screw and was hanging on the rod, without being on the screw itself.During surgery (today) they were tapping with a 10 mm tap before putting in 10x80 viper cortical fix screw in the old ilium fixation (they took out 9x80) the two polyaxial screw driver broke, and the viper screwdriver.The viper part got stuck in the screw while it was half way in the bone, they tried to take it out, but with no luck, leaving it to no other chose than saw of the part that was outside the bone, leaving the rest in the patient.Then they took an exp verse below that (8x80) with success.Final tightening after rod insertion.Some of the sets screws that was taken out had some marks on them.

Manufacturer Narrative

Product complaint #
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> (b)(4).Visual examination of the setscrew revealed signs of operative use as evidence by superficial markings.Weak rod striations were observed on the set screw suggesting that the set screw was not seated properly.A review of the device history record (dhr) for the single inner setscrew could not be performed as the lot number is illegible.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the set screw becoming loose cannot be positively determined.However, the weak, rod striations observed on the set screw suggests that the set screw were not properly tightened on to the rod, resulting in the set screw becoming loose.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SINGLE-INNER SETSCREW
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 8187132
• MDR Text Key: 131140714
• Report Number: 1526439-2018-51181
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034064307
• UDI-Public: (01)10705034064307
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179702000
• Device Catalogue Number: 179702000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention